The CRL was given because the FDA did not consider the phase 1/2 IGNYTE trial to be an adequate and well-controlled clinical ...

Atara Biotherapeutics Inc (NASDAQ:ATRA) saw its stock jump 7% following the U.S. Food and Drug Administration’s acceptance of ...

Among reasons for the rejection, the agency cited a lack of US patient representation in the STARGLO trial assessing ...

In a complete response letter, the FDA indicates the drug trial is not an adequate, well-controlled clinical investigation, ...

These updates support Ocugen in its efforts to pursue its goal of 3 biologics license applications (BLA) in the next 3 years.

The FDA has issued a complete response letter to Replimune indicating it is unable to approve the biologics license ...

The FDA cited trial design concerns and lack of substantial evidence in denying approval for Replimune’s biologics license application in advanced melanoma.

Shares fell 75% to $3.04, putting the stock on track for a record closing low, according to Dow Jones Market Data. The stock ...

Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration ...